Breast Cancer
Conditions
Brief summary
The study objective is to determine the MarginProbe® System's diagnostic accuracy at the margin level and impact on Positive Margin\* Presence originating from the Main ex-vivo lumpectomy specimen after the initial lumpectomy surgery. \*A positive margin is defined in this study as a margin microscopically measured and reported in the histology report to have cancer within 1 mm or less of the inked surface
Detailed description
This is a prospective, multicenter, randomized (1:1), double arm, controlled study, in which subjects undergoing breast excision (lumpectomy) for carcinoma of the breast will be randomized to either standard of care with additional inspection ('SOC + Additional inspection' arm) or standard of care with MarginProbe as an adjunct ('SOC + Device' arm). The MarginProbe is an adjunctive diagnostic tool for identification of cancerous tissue at the margins (≤ 1mm) of the main ex-vivo lumpectomy specimen following primary excision. It will be used by the surgeon during lumpectomy procedures only in patients randomized to the Device+SOC arm. Randomization will take place following the excision of the main ex-vivo lumpectomy specimen.
Interventions
DEVICEMargin Probe
The surgeon will use the MarginProbe System to identify cancerous tissue at the margins (≤ 1mm) of the main ex-vivo lumpectomy specimen following primary excision
OTHERControl: Additional inspection
The surgeon will perform additional inspection and assessment of the margins of the main ex-vivo lumpectomy specimen following primary excision
Sponsors
Dune Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women histologically diagnosed with carcinoma of the breast * Women with non-palpable malignant lesions, requiring image guided localization. * Undergoing lumpectomy (partial mastectomy) procedure * Age 18 years or more * Signed ICF
Exclusion criteria
* Multi-centric disease (histologically diagnosed cancer in two different quadrants of the breast) * Bilateral disease (diagnosed cancer in both breasts) * Neo-adjuvant systemic therapy * Previous radiation in the operated breast * Prior surgery in the same site in the breast * Woman histologically diagnosed by an open biopsy procedure * Implants in the operated breast * Pregnancy * Lactation * Participating in any other investigational study for either drug or device which could influence collection of valid data under this study * Patients for whom complete cavity shaving is planned (sites where this is the routine practice of the investigator will also be excluded from participation in the study)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy at the margin level | Participants will be followed only for the initial lumpectomy duration. information will be available 2-3 weeks (avarage) from initial lumpectomy date | Sensitivity and Specificity at the margin level; |
| Incomplete Surgical Resection (ISR ) | Participants will be followed only for the initial lumpectomy duration. information will be available 2-3 weeks (avarage) from initial lumpectomy date | ISR - Positive Margin on the Main ex-vivo lumpectomy specimen after the initial lumpectomy surgery, that was not addressed by taking a shaving(s) corresponding to the positive margin(s). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Repeat lumpectomy rate | Participants will be followed for 2-5 weeks (average) | Proportion of patients who underwent a repeat lumpectomy procedure |
| Positive Margin presence on the Outermost Shaving after the initial lumpectomy surgery | Participants will be followed only for the initial lumpectomy duration. information will be available 2-3 weeks (avarage) from initial lumpectomy date | Proportion of patients with Positive Margin presence on the Outermost Shaving after the initial lumpectomy surgery |
| Diagnostic Accuracy at the Patient Level (ignoring location) | Participants will be followed only for the initial lumpectomy duration. information will be available 2-3 weeks (avarage) from initial lumpectomy date | Proportion of patients from whom shavings were taken |
| Repeat lumpectomy and mastectomy rate | Participants will be followed for 2-5 weeks (average) | Proportion of patients who underwent a repeat lumpectomy procedure or a mastectomy |
| Cosmesis evaluation | participants will be followed until 6 months ± 1 month after last surgical treatment visit, an avarage of of 8 months following initial lumpectomy | Objective evaluation by an evaluator blinded to arm assignment |
Countries
United States
Outcome results
None listed